Impact of Anatomy-Based Cochlear Implant Programming on Early Performance

Not Applicable

Not yet recruiting

• Conditions: Hearing Loss, Unilateral; Cochlear Implants; Hearing Loss, Sensorineural; Single-Sided Deafness (SSD); Asymmetric Hearing Loss

• Registration Number: NCT06734039
• Lead Sponsor: Med-El Corporation

Brief Summary

The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear.

Detailed Description

Participants will be randomized into a starting frequency setting at device activation or shortly after device activation for the first three months of device use. After 3 months listening experience, participants will be randomized into different frequency settings and tested before and after a period of listening experience. Participant outcomes for each of the multiple frequency settings will be evaluated using standard clinical speech testing and through questionnaires designed to capture information about patient sound quality and quality of life.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13
• Study Start: 2025-04-30
• Primary Completion: 2028-04
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

• Subjects who do not meet one or more of the above-mentioned inclusion criteria are excluded from the study
• Subjects required to use a hearing aid per inclusion criteria who stop use of a hearing aid in the contralateral ear will be withdrawn at the time of discontinued hearing aid use
• Subjects who receive a cochlear implant in the contralateral ear prior to the 12-month interval

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Percent correct on AzBio Sentences in Noise	3 to 7 months	The AzBio sentence test, consisting of lists of 20 sentences spoken by male and female talkers, will be tested in noise in three spatial listening conditions with after listening experience with each frequency setting. Listening conditions include co-located presentation of the target and noise, target presented with noise to the implanted ear, and target presented with noise to the opposite acoustic hearing ear. Outcomes will be reported as percent correct (%).
Cochlear Implant Quality of Life - 35 Profile (CIQoL 35)	Enrollment to 7 months	Subjects will complete a 35-item questionnaire with a total score ranging from 0-100% (higher score indicates a higher level of functional ability with a cochlear implant) regarding their subjective listening experience in 6 domains: communication, emotional, entertainment, environment, listening effort, social.

Secondary Outcome Measures

Name	Time	Method
Percent Correct on Az Bio Sentences in Noise	12 months	The AzBio sentence test, consisting of lists of 20 sentences spoken by male and female talkers, will be tested in noise in three spatial listening conditions with after listening experience with each frequency setting. Listening conditions include co-located presentation of the target and noise, target presented with noise to the implanted ear, and target presented with noise to the opposite acoustic hearing ear. Outcomes will be reported as percent correct (%).
Percent Correct on Consonant Nucleus Consonant (CNC) Words	3 to 12 months	The CNC test, consisting of 50 words scored as percent correct, will be tested in quiet after listening experience with each frequency setting for the implanted ear alone.
Post-operative Audiogram	Enrollment and 12 months	Unaided pure-tone audiometric thresholds will be tested for both ears. For patients with moderate to moderately severe hearing loss in the unimplanted ear, thresholds will also be tested in the best-aided condition.
Subjective feedback questionnaire	Enrollment to 12 months	Subjects will complete a non-validated subjective questionnaire assessing their perceptual sound quality prior to and after listening experience with different frequency settings. The questionnaire utilizes multiple choice questions, a 5-point Likert scale, and open-ended questions intended to collect subject feedback.
Psychoacoustic Testing of Sound Quality and Preference	7 months	Subjects will listen to speech and non-speech sounds will rate the quality of each sound on a 6-point Likert scale using different frequency settings. Subjects will then be asked to rank the different frequency settings relative to each other for quality and preference.
Cochlear Implant Quality of Life- 35 Profile (CIQoL35)	12 months	Subjects will complete a 35-item questionnaire with a total score ranging from 0-100% (higher score indicates a higher level of functional ability with a cochlear implant) regarding their subjective listening experience in 6 domains: communication, emotional, entertainment, environment, listening effort, social.
Decisional Regret Scale	3 to 12 months	A validated questionnaire using a 5-point Likert scale to assess decisional regret after cochlear implantation.

Trial Locations

Locations (1)

MED-EL Corporation; 🇺🇸 Durham, North Carolina, United States